Evaluating pleural lavage cytology in patients with resectable esophageal cancer
A Prospective Study for Pleural Lavage Cytology in Patients With Esophageal Cancer
This study tests if a procedure called pleural lavage cytology can help doctors better understand the chances of recovery for patients with esophageal cancer who are having surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 385 (estimated) |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Locations | 11 sites (Hefei, Anhui and 10 other locations) |
| Trial ID | NCT05443841 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the value of pleural lavage cytology (PLC) in patients with resectable esophageal cancer. The study will involve performing PLC before and after esophageal resection to determine the frequency of positive results and their association with patient survival and postoperative treatment efficacy. By identifying risk factors for disease recurrence and metastasis, the study seeks to improve outcomes for patients undergoing curative treatment for esophageal cancer.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed, resectable esophageal cancer at clinical stages T1-4a/N0-3/M0 who are eligible for R0 resection.
Not a fit: Patients with severe major organ dysfunction, those who have undergone endoscopic submucosal dissection or endoscopic mucosal resection, or those for whom pleural lavage is not feasible due to adhesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict disease recurrence and improve survival rates for patients with esophageal cancer.
How similar studies have performed: While pleural lavage cytology has shown promise in lung cancer, its application in esophageal cancer is less established, making this study a novel exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * esophageal cancer with histological confirmation before treatment. * resectable esophageal cancer with clinical T1-4a/N0-3/M0 staging * potential R0 resection * no history of other malignancies Exclusion Criteria: * severe major organ dysfunction (American society of anesthesiologisits score \>3 ) * patients underwent ESD or EMR * pleural lavage is unavailable due to adhesions
Where this trial is running
Hefei, Anhui and 10 other locations
- The First Affiliated Hospital of USTC — Hefei, Anhui, China (Not_yet_recruiting)
- The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
- Henan Provincial People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
- Nantong Tumor Hospital — Nantong, Jiangsu, China (Not_yet_recruiting)
- The Second Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Not_yet_recruiting)
- Taixing People's Hospital — Taishing, Jiangsu, China (Recruiting)
- Taizhou People's Hospital — Taizhou, Jiangsu, China (Not_yet_recruiting)
- Shaanxi Provincial cancer Hospital — Xi'an, Shaanxi, China (Not_yet_recruiting)
- The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shannxi, China (Not_yet_recruiting)
- Tianjin Medical University Cancer Institute — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
- Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Haiquan Chen, MD — Fudan University
- Study coordinator: Bin Li, MD
- Email: lb0256327@hotmail.com
- Phone: 086-64175590-82500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.